German Oncological Data Standard (GOLD)
0.1.0 - CI Build
German Oncological Data Standard (GOLD)
0.1.0 - CI Build
German Oncological Data Standard (GOLD) - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
@prefix fhir: <http://hl7.org/fhir/> . @prefix owl: <http://www.w3.org/2002/07/owl#> . @prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> . @prefix sct: <http://snomed.info/id/> . @prefix xsd: <http://www.w3.org/2001/XMLSchema#> . # - resource ------------------------------------------------------------------- a fhir:ResearchStudy ; fhir:nodeRole fhir:treeRoot ; fhir:id [ fhir:v "ExampleStudyRAAINBOW"] ; # fhir:meta [ ( fhir:profile [ fhir:v "https://www.vision-zero-oncology.de/fhir/StructureDefinition/clinical-study"^^xsd:anyURI ; fhir:link <https://www.vision-zero-oncology.de/fhir/StructureDefinition/clinical-study> ] ) ] ; # fhir:text [ fhir:status [ fhir:v "generated" ] ; fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: ResearchStudy</b><a name=\"ExampleStudyRAAINBOW\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource ResearchStudy "ExampleStudyRAAINBOW" </p><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-clinical-study.html\">Profile Clinical Study</a></p></div><p><b>identifier</b>: id: NCT03240627</p><p><b>title</b>: Double-blind, Vehicle-controlled, Randomised, Multi-centre Study to Evaluate the Efficacy and Safety of LH-8 Cutaneous Solution in Children and Adolescents With Moderate to Severe Scalp Alopecia Areata.</p><p><b>status</b>: completed</p><p><b>primaryPurposeType</b>: Treatment <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-prim-purp-type.html\">ResearchStudyPrimaryPurposeType</a>#treatment)</span></p><p><b>phase</b>: Phase 2/Phase 3 <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-phase.html\">ResearchStudyPhase</a>#phase-2-phase-3)</span></p><p><b>category</b>: Interventional Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C98388)</span>, Randomized Controlled Clinical Trial <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C46079)</span>, Double Blind Study <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C15228)</span>, Unequal Randomization <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C142743)</span></p><p><b>focus</b>: Pharmacologic Substance <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C1909)</span></p><p><b>condition</b>: Alopecia areata (disorder) <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"https://browser.ihtsdotools.org/\">SNOMED CT</a>#68225006)</span></p><p><b>location</b>: Germany <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#DE)</span>, France <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-ISO3166Part1.html\">ISO 3166-1 Codes for the representation of names of countries and their subdivisions — Part 1: Country code</a>#FR)</span></p><p><b>period</b>: 2018-03-01 --> 2022-03-17</p><p><b>principalInvestigator</b>: <a href=\"https://simplifier.net/resolve?scope=de.basisprofil.r4@1.4.0&canonical=http://fhir.org/packages/de.basisprofil.r4/Practitioner/example\">Practitioner/example</a></p><p><b>site</b>: </p><ul><li><a href=\"https://simplifier.net/resolve?scope=de.basisprofil.r4@1.4.0&canonical=http://fhir.org/packages/de.basisprofil.r4/Organization/Charite-dermatology\">Organization/Charite-dermatology</a></li><li><a href=\"https://simplifier.net/resolve?scope=de.basisprofil.r4@1.4.0&canonical=http://fhir.org/packages/de.basisprofil.r4/Organization/Sabouraud-Center\">Organization/Sabouraud-Center</a></li><li><a href=\"https://simplifier.net/resolve?scope=de.basisprofil.r4@1.4.0&canonical=http://fhir.org/packages/de.basisprofil.r4/Organization/Diagnostic-consulting-center-XXIV-Sofia\">Organization/Diagnostic-consulting-center-XXIV-Sofia</a></li><li><a href=\"https://simplifier.net/resolve?scope=de.basisprofil.r4@1.4.0&canonical=http://fhir.org/packages/de.basisprofil.r4/Organization/SC-Centrul-Medical-Sana-SRL\">Organization/SC-Centrul-Medical-Sana-SRL</a></li></ul><blockquote><p><b>arm</b></p><p><b>name</b>: Experimental: LH-8 cutaneous solution</p><p><b>type</b>: Investigational Arm <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C174266)</span></p><p><b>description</b>: LH-8 cutaneous solution (0.126 mL per spray) applied to the whole scalp</p></blockquote><blockquote><p><b>arm</b></p><p><b>name</b>: Placebo Comparator: Placebo cutaneous solution</p><p><b>type</b>: Control Arm <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-v3-nciThesaurus.html\">NCI Thesaurus</a>#C174226)</span></p><p><b>description</b>: Placebo cutaneous solution (0.126 mL per spray) applied to the whole scalp</p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment. [ Time Frame: 24 weeks treatment ] Visual assessment and global standardised scalp photographs for SALT evaluation.</p><p><b>type</b>: Primary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#primary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Absolute change in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Proportion of the responders, i.e. subjects achieving at least a 40% relative reduction in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Adverse events [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: General physical examination findings, including irritation of eyes and skin [ Time Frame: 24 weeks treatment ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Visual assessment and global standardised scalp photographs for SALT evaluation. [ Time Frame: After 12 and 24 weeks treatment ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Evaluation of duration of treatment effect in responders, measured as relative SALT score changes from Visit 3 (end of treatment) after 12 weeks (Visit 4) and 24 weeks (Visit 5) of treatment-free period. (Visual assessment and global standardised scalp photographs for SALT evaluation.)</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Assessment of treatment effect on hair follicles in non-alopecic areas by quantifying the number of new alopecic areas. [ Time Frame: 24 weeks treatment ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Assessment of the rate of spontaneous hair regrowth. [ Time Frame: For 6-12 months ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Assessment of the rate of spontaneous hair regrowth in placebo treated subjects with alopecia areata active for 6-12 months compared to those with alopecia areata active for more than 12 months. (Visual assessment and global standardised scalp photographs for SALT evaluation).</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Absolute and relative change from baseline in Children's Dermatology Life Quality Index (CDLQI) scores. [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Change in percentage of subjects from baseline by the severity banding CDLQI scores. [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Percentages of subjects by EuroQol Five Dimensions Youth Questionnaire (EQ-5D-Y) dimensions and levels at Visits 1-5. [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Absolute and relative change of the EQ-Visual Analogue Scale (EQ-VAS) scores from baseline [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote><blockquote><p><b>objective</b></p><p><b>name</b>: Evaluation of the Paediatric Alopecia Areata Patient Benefit Index (PAAPBI) scores at Visits 1 to 5. [ Time Frame: 48 weeks ]</p><p><b>type</b>: Secondary <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (<a href=\"http://terminology.hl7.org/5.3.0/CodeSystem-research-study-objective-type.html\">ResearchStudyObjectiveType</a>#secondary)</span></p></blockquote></div>" ] ; # fhir:identifier ( [ fhir:system [ fhir:v "http://clinicaltrials.gov"^^xsd:anyURI ] ; fhir:value [ fhir:v "NCT03240627" ] ] ) ; # fhir:title [ fhir:v "Double-blind, Vehicle-controlled, Randomised, Multi-centre Study to Evaluate the Efficacy and Safety of LH-8 Cutaneous Solution in Children and Adolescents With Moderate to Severe Scalp Alopecia Areata."] ; # fhir:status [ fhir:v "completed"] ; # fhir:primaryPurposeType [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-prim-purp-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "treatment" ] ] ) ] ; # fhir:phase [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-phase"^^xsd:anyURI ] ; fhir:code [ fhir:v "phase-2-phase-3" ] ; fhir:display [ fhir:v "Phase 2/Phase 3" ] ] ) ] ; # fhir:category ( [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C98388" ] ; fhir:display [ fhir:v "Interventional Study" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C46079" ] ; fhir:display [ fhir:v "Randomized Controlled Clinical Trial" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C15228" ] ; fhir:display [ fhir:v "Double Blind Study" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C142743" ] ; fhir:display [ fhir:v "Unequal Randomization" ] ] ) ] ) ; # fhir:focus ( [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C1909" ] ; fhir:display [ fhir:v "Pharmacologic Substance" ] ] ) ] ) ; # fhir:condition ( [ ( fhir:coding [ a sct:68225006 ; fhir:system [ fhir:v "http://snomed.info/sct"^^xsd:anyURI ] ; fhir:code [ fhir:v "68225006" ] ; fhir:display [ fhir:v "Alopecia areata (disorder)" ] ] ) ] ) ; # fhir:location ( [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "DE" ] ; fhir:display [ fhir:v "Germany" ] ] ) ] [ ( fhir:coding [ fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ; fhir:code [ fhir:v "FR" ] ; fhir:display [ fhir:v "France" ] ] ) ] ) ; # fhir:period [ fhir:start [ fhir:v "2018-03-01"^^xsd:date ] ; fhir:end [ fhir:v "2022-03-17"^^xsd:date ] ] ; # fhir:principalInvestigator [ fhir:reference [ fhir:v "Practitioner/example" ] ] ; # fhir:site ( [ fhir:reference [ fhir:v "Organization/Charite-dermatology" ] ] [ fhir:reference [ fhir:v "Organization/Sabouraud-Center" ] ] [ fhir:reference [ fhir:v "Organization/Diagnostic-consulting-center-XXIV-Sofia" ] ] [ fhir:reference [ fhir:v "Organization/SC-Centrul-Medical-Sana-SRL" ] ] ) ; # fhir:arm ( [ fhir:name [ fhir:v "Experimental: LH-8 cutaneous solution" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C174266" ] ; fhir:display [ fhir:v "Investigational Arm" ] ] ) ] ; fhir:description [ fhir:v "LH-8 cutaneous solution (0.126 mL per spray) applied to the whole scalp" ] ] [ fhir:name [ fhir:v "Placebo Comparator: Placebo cutaneous solution" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ; fhir:code [ fhir:v "C174226" ] ; fhir:display [ fhir:v "Control Arm" ] ] ) ] ; fhir:description [ fhir:v "Placebo cutaneous solution (0.126 mL per spray) applied to the whole scalp" ] ] ) ; # fhir:objective ( [ fhir:name [ fhir:v "Relative change in scalp alopecia areata severity scores (SALT) from baseline value to be assessed after 24 weeks of treatment. [ Time Frame: 24 weeks treatment ] Visual assessment and global standardised scalp photographs for SALT evaluation." ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "primary" ] ] ) ] ] [ fhir:name [ fhir:v "Absolute change in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "secondary" ] ] ) ] ] [ fhir:name [ fhir:v "Proportion of the responders, i.e. subjects achieving at least a 40% relative reduction in SALT score from baseline at the end of 24 weeks' treatment period. [ Time Frame: 24 weeks treatment ]" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "secondary" ] ] ) ] ] [ fhir:name [ fhir:v "Adverse events [ Time Frame: 48 weeks ]" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "secondary" ] ] ) ] ] [ fhir:name [ fhir:v "General physical examination findings, including irritation of eyes and skin [ Time Frame: 24 weeks treatment ]" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "secondary" ] ] ) ] ] [ fhir:name [ fhir:v "Visual assessment and global standardised scalp photographs for SALT evaluation. [ Time Frame: After 12 and 24 weeks treatment ]" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "secondary" ] ] ) ] ] [ fhir:name [ fhir:v "Evaluation of duration of treatment effect in responders, measured as relative SALT score changes from Visit 3 (end of treatment) after 12 weeks (Visit 4) and 24 weeks (Visit 5) of treatment-free period. (Visual assessment and global standardised scalp photographs for SALT evaluation.)" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "secondary" ] ] ) ] ] [ fhir:name [ fhir:v "Assessment of treatment effect on hair follicles in non-alopecic areas by quantifying the number of new alopecic areas. [ Time Frame: 24 weeks treatment ]" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "secondary" ] ] ) ] ] [ fhir:name [ fhir:v "Assessment of the rate of spontaneous hair regrowth. [ Time Frame: For 6-12 months ]" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "secondary" ] ] ) ] ] [ fhir:name [ fhir:v "Assessment of the rate of spontaneous hair regrowth in placebo treated subjects with alopecia areata active for 6-12 months compared to those with alopecia areata active for more than 12 months. (Visual assessment and global standardised scalp photographs for SALT evaluation)." ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "secondary" ] ] ) ] ] [ fhir:name [ fhir:v "Absolute and relative change from baseline in Children's Dermatology Life Quality Index (CDLQI) scores. [ Time Frame: 48 weeks ]" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "secondary" ] ] ) ] ] [ fhir:name [ fhir:v "Change in percentage of subjects from baseline by the severity banding CDLQI scores. [ Time Frame: 48 weeks ]" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "secondary" ] ] ) ] ] [ fhir:name [ fhir:v "Percentages of subjects by EuroQol Five Dimensions Youth Questionnaire (EQ-5D-Y) dimensions and levels at Visits 1-5. [ Time Frame: 48 weeks ]" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "secondary" ] ] ) ] ] [ fhir:name [ fhir:v "Absolute and relative change of the EQ-Visual Analogue Scale (EQ-VAS) scores from baseline [ Time Frame: 48 weeks ]" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "secondary" ] ] ) ] ] [ fhir:name [ fhir:v "Evaluation of the Paediatric Alopecia Areata Patient Benefit Index (PAAPBI) scores at Visits 1 to 5. [ Time Frame: 48 weeks ]" ] ; fhir:type [ ( fhir:coding [ fhir:system [ fhir:v "http://terminology.hl7.org/CodeSystem/research-study-objective-type"^^xsd:anyURI ] ; fhir:code [ fhir:v "secondary" ] ] ) ] ] ) . #
IG © 2021+ Berlin Institute of Health at Charité (BIH). Package gold#0.1.0 based on FHIR 4.0.1. Generated 2023-12-13
Links: Table of Contents |
QA Report